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Abstract:

A reduced-pressure, linear-wound closing bolster has a pivotable frame
that moves from an extended position to a compressed position under the
influence of reduced pressure. The closing bolster may have a first
closing member, a second closing member, and an interior space. A
manifold member is disposed within the interior space and may be coupled
to the pivotable frame. When a reduced pressure is applied, the pivotable
frame is urged from the extended position to the compressed position. A
first gripping member for transmitting a closing force from the first
closing member to a first edge of a linear wound may be attached.
Likewise, a second gripping member for transmitting a closing force from
the second closing member to a second edge of the linear wound may be
attached. Systems and methods are also presented.

Claims:

1. A reduced-pressure, linear-wound closing bolster for managing a linear
wound, the bolster comprising: a pivotable frame having a first closing
member and a second closing member pivotably coupled to the first closing
member and forming an interior space between the first closing member and
the second closing member; a manifold member disposed within the interior
space; a first gripping member coupled to the first closing member; and a
second gripping member coupled to the second closing member; wherein the
pivotable frame is operable to move between an extended position and a
contracted position under a reduced pressure applied to the manifold
member to transmit a closing force to the linear wound through the first
and second gripping members.

2. The reduced-pressure, linear-wound closing bolster of claim 1 wherein
the pivotable frame comprises: the first closing member; the second
closing member; a connecting member; a first pivot connector coupling the
first closing member and the connecting member; and a second pivot
connector coupling the second closing member and the connecting member.

3. The reduced-pressure, linear-wound closing bolster of claim 1 wherein
the pivotable frame comprises: the first closing member; the second
closing member; and a pivot connector for coupling the first closing
member and second closing member.

4. The reduced-pressure, linear-wound closing bolster of claim 1 wherein
the first gripping member comprises a first adhesive strip and the second
gripping member comprises a second adhesive strip.

5. The reduced-pressure, linear-wound closing bolster of claim 1 wherein
the first gripping member comprises a first high-friction member coupled
to the first closing member and the second gripping member comprises a
second high-friction member coupled to the second closing member.

6. The reduced-pressure, linear-wound closing bolster of claim 1 wherein
the pivotable frame is open on a first end and a second end.

7. (canceled)

8. A reduced-pressure, linear-wound closing bolster for closing a linear
wound, the bolster comprising: a first closing member for placing on a
first side of the linear wound, the first closing member having a first
longitudinal edge, a second longitudinal edge, and an interior surface; a
second closing member for placing on a second side of the linear wound,
the second closing member having a first longitudinal edge, a second
longitudinal edge, and an interior surface; a connecting member having a
first longitudinal edge and a second longitudinal edge; a first pivot
connector coupling the first longitudinal edge of the first closing
member and the first longitudinal edge of the connecting member, wherein
the first pivot connector allows movement of the first closing member
with respect to the connecting member; a second pivot connector coupling
the first longitudinal edge of the second closing member and the second
longitudinal edge of the connecting member, wherein the second pivot
connector allows movement of the second closing member with respect to
the connecting member; a manifold member coupled to the interior surface
of the first closing member and the interior surface of the second
closing member, and wherein the manifold member contracts when placed
under a reduced pressure; and an interface fluidly coupled to the
manifold for delivering the reduced pressure thereto.

9. The closing bolster of claim 8 wherein the first closing member and
second closing member each have a lateral axis in cross section and
wherein the lateral axis of the first closing member and second closing
member each form an angle α with respect to a reference line (in
cross section) that is normal to a patient's skin, and wherein a is a
non-zero value such that when a force is placed on the bolster in the
direction of the linear wound, the bolster will develop an inward force.

10. The closing bolster of claim 8, wherein wherein the first closing
member further comprises a first lateral edge and a second lateral edge;
wherein the second closing member further comprises a first lateral edge
and a second lateral edge; wherein the connecting member further
comprises a first lateral edge and a second lateral edge; further
comprising: a first end cap associated with the first lateral edge of the
first closing member, first lateral edge of the second closing member,
and first lateral edge of the connecting member, and a second end cap
associated with the second lateral edge of the first closing member,
second lateral edge of the second closing member, and second lateral edge
of the connecting member; and wherein the connecting member, first
closing member, second closing member, first end cap, and second end cap
are operable to form a fluid seal against a patient's skin.

11.-27. (canceled)

28. A reduced-pressure, linear-wound closing bolster for managing a
linear wound, the bolster comprising: a first closing member; a second
closing member; a connecting member; a first pivot connector coupling the
first closing member to the connecting member and a second pivot
connector coupling the second closing member to the connecting member;
and an interior space formed at least in part by the first closing member
and the second closing member; a manifold member disposed within the
interior space and coupled to the first closing member and second closing
member; a first gripping member; and a second gripping member; wherein
the first gripping member and the second gripping member are operable to
apply a closing force to the linear wound under a reduced pressure
applied to the manifold member.

29. The reduced-pressure, linear-wound closing bolster of claim 28,
wherein: the first pivot connector is pivotably coupled to a longitudinal
edge of the first closing member and to a first longitudinal edge of the
connecting member; and the second pivot connector is pivotably coupled to
a longitudinal edge of the second closing member and to a second
longitudinal edge of the connecting member.

30. The reduced-pressure, linear-wound closing bolster of claim 28,
wherein: the first pivot connector is a first hinge coupled to a
longitudinal edge of the first closing member and to a first longitudinal
edge of the connecting member; and the second pivot connector is a second
hinge coupled to a longitudinal edge of the second closing member and to
a second longitudinal edge of the connecting member.

31. The reduced-pressure, linear-wound closing bolster of claim 28,
wherein: the first closing member, the second closing member, and the
connecting member form a pivotable frame; the first pivot connector is a
first bendable relief in the pivotable frame; and the second pivot
connector is a second bendable relief in the pivotable frame.

32. The reduced-pressure, linear-wound closing bolster of claim 28,
further comprising an interface fluidly coupled to the manifold member
for delivering the reduced pressure thereto.

33. The reduced-pressure, linear-wound closing bolster of claim 1,
wherein the first closing member and the second closing member are
pivotably coupled along a longitudinal edge of the pivotable frame.

34. The reduced-pressure, linear-wound closing bolster of claim 1,
wherein the first closing member and the second closing member are
pivotably coupled through a hinge along a longitudinal edge of the
pivotable frame.

35. The reduced-pressure, linear-wound closing bolster of claim 1,
wherein the pivotable frame further comprises: a connecting member
pivotably coupled along a first longitudinal edge to the first closing
member and along a second longitudinal edge to the second closing member.

36. The reduced-pressure, linear-wound closing bolster of claim 1,
wherein the pivotable frame further comprises: a connecting member
pivotably coupled along a first longitudinal edge to the first closing
member through a first hinge and along a second longitudinal edge to the
second closing member through a second hinge.

37. The reduced-pressure, linear-wound closing bolster of claim 1,
wherein the first closing member and the second closing member are
pivotably coupled through a bendable relief along a longitudinal edge of
the pivotable frame.

38. The reduced-pressure, linear-wound closing bolster of claim 1,
further comprising an interface fluidly coupled to the manifold member
for delivering the reduced pressure thereto.

[0003] Physicians perform millions of surgical procedures each year around
the world. Many of the procedures are performed as open surgery and an
increasing number are performed using minimally invasive surgery, such as
arthroscopic, laparoscopic, and endoscopic procedures. However performed,
surgical procedures involve acute wounds, e.g., an incision, in the skin
and related tissue. In many instances, the incision is closed at the
conclusion of the procedure using a mechanical apparatus, such as staples
or sutures, and the wound is merely covered with a dry, sterile bandage.

[0004] The use of staples or sutures to close an acute wound may have
undesirable side effects. For example, staples and sutures can proximate
the wound edges tightly where they are applied, but in between such
mechanical closing devices are gaps or areas that are not as tightly
closed. This may lead to areas of high stress proximate the closing
device interspersed with areas of relatively low stress in between. This
may, in turn, influence scarring, healing time, and strength of the
wound.

BRIEF SUMMARY

[0005] Shortcomings with certain aspects of linear wound care are
addressed by the present invention as shown and described in a variety of
illustrative embodiments herein. "Linear wound" refers generally to a
laceration or incision whether in a line or not. According to an
illustrative embodiment, a reduced-pressure, linear-wound closing bolster
for managing a linear wound includes a pivotable frame having a first
closing member, a second closing member, and an interior space. The
pivotable frame is operable to move between an extended position and a
contracted position. The closing bolster further includes a manifold
member disposed within the interior space, a first gripping member
coupled to the first closing member, and a second gripping member coupled
to the second closing member. The first gripping member is for
transmitting a closing force from the first closing member to a first
edge of the linear wound. The second gripping member is for transmitting
a closing force from the second closing member to a second edge of the
linear wound.

[0006] According to another illustrative embodiment, a reduced-pressure,
linear-wound closing bolster includes a first closing member for placing
on a first side of the linear wound, a second closing member for placing
on a second side of the linear wound, and a first connecting member. The
bolster also includes a first pivot connector coupling a portion of the
first closing member and the connecting member, a second pivot connector
coupling a portion of the second member and the connecting member, and a
manifold member coupled to an interior surface of the first closing
member and an interior surface of the second closing member. The manifold
member contracts when placed under a reduced pressure. The bolster also
includes an interface fluidly coupled to the manifold for delivering a
reduced pressure thereto.

[0007] According to another illustrative embodiment, a reduced-pressure,
linear wound treatment system includes a closing bolster for placing on
the patient's skin over a linear wound and operable to move between an
extended position and a compressed position. The closing bolster
comprises a pivotable frame having an interior space and a manifold
disposed within the interior space and coupled to the pivotable frame.
The system includes a sealing subsystem for providing a fluid seal
between the closing bolster and the patient, and a reduced-pressure
subsystem for delivering a reduced pressure to the sealing subsystem. The
sealing subsystem and reduced-pressure subsystem are operable to deliver
a reduced pressure to the closing bolster, and the closing bolster is
operable under reduced pressure to go to the compressed position and
thereby develop an inward force.

[0008] According to one illustrative embodiment, a reduced-pressure,
anisotropic closing bolster includes an anisotropic manifold member
operable under reduced pressure to contract more in a lateral direction
than in a longitudinal direction. The anisotropic manifold member
includes a plurality of longitudinal manifold members of a flexible
manifold material, a plurality of reinforcing members, and an anisotropic
bolster body formed by coupling the plurality of longitudinal manifold
members and the plurality of reinforcing members. The anisotropic bolster
body is operable under reduced pressure to contract more perpendicularly
to the plurality of reinforcing members than parallel to the plurality of
reinforcing members.

[0009] According to another illustrative embodiment, a method of applying
a closing force to a linear wound on a patient includes providing a
reduced-pressure, linear-wound closing bolster. Wherein the
reduced-pressure, linear-wound closing bolster includes a manifold member
and a pivotable frame that has an interior space and a first closing
member and a second closing member. The first closing member has a first
longitudinal edge and a second longitudinal edge. The second closing
member has first longitudinal edge and a second longitudinal edge. The
method includes placing the second longitudinal edge of the first closing
member proximate a first edge of the linear wound and placing the second
longitudinal edge of the second closing member proximate a second edge of
the linear wound. The method also includes forming a fluid seal between
the pivotable frame and the patient's skin, coupling a reduced-pressure
subsystem to an interface to the manifold member, and activating the
reduced-pressure source.

[0010] According to another illustrative embodiment, a method of
manufacturing a reduced-pressure, linear-wound closing bolster includes
forming a pivotable frame having first closing member, a second closing
member, and an interior space, the pivotable frame operable to move
between an extended position and a contracted position. The method
includes disposing a manifold member within the interior space and
providing a first gripping member operable to transmit a closing force
from the first closing member to a first edge of a linear wound. The
method also includes providing a second gripping member operable to
transmit a closing force from the second closing member to a second edge
of the linear wound. The method may further include coupling the manifold
member to the pivotable frame such that when a reduced pressure is
applied, the pivotable frame is urged from the extended position to the
contracted position.

[0011] According to one illustrative embodiment, a reduced-pressure,
linear-wound closing bolster for managing a linear wound includes a first
closing member, a second closing member, a pivot connector coupling the
first closing member and second closing member, and an interior space
formed at least in part by the first closing member and the second
closing member. The pivot connector is operable to move between an
extended position and a compressed position. The closing bolster further
includes a manifold member disposed within the interior space and coupled
to the first closing member and second closing member such that when
reduced pressure is applied, the pivotable frame is urged from the
extended position to the compressed position. The closing bolster also
includes a first gripping member for transmitting a closing force from
the first closing member to a first edge of a linear wound and a second
gripping member for transmitting a closing force from the second closing
member to a second edge of the linear wound.

[0012] The illustrative embodiments may provide a number of advantages. A
couple of examples follow. Technical advantages of the illustrative
embodiments are perceived to include that the wound might be able to
withstand more force during the healing process. Additionally, the wound
edges that otherwise would not be tightly and smoothly approximated are
healed in a tight position with the edges approximated. The time for the
wound to gain strength may be decreased. It may also reduce the scar
formation at the wound. These are just some possible examples.

[0013] Other objects, features, and advantages of the illustrative
embodiments will become apparent with reference to the drawings and
detailed description that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] A more complete understanding of the method and apparatus of the
present invention may be obtained by reference to the following Detailed
Description when taken in conjunction with the accompanying Drawings
wherein:

[0015] FIG. 1 is a schematic, cross-sectional view of an illustrative
embodiment of a reduced-pressure, linear wound closing system;

[0016]FIG. 2 is a schematic detail of a first closure member of the
illustrative embodiment of FIG. 1;

[0017]FIG. 3A is a schematic, cross-sectional view of an illustrative
embodiment of a reduced-pressure, linear wound closing bolster shown in
an extended position;

[0018]FIG. 3B is a schematic, perspective view of the closing bolster of
FIG. 3A also shown in the extended position;

[0019]FIG. 3C is a schematic, cross-sectional view of the closing bolster
of FIGS. 3A and 3B shown in a compression position;

[0021]FIG. 5 is a schematic, cross-sectional view of a linear wound
showing the development of collagen parallel to the closing force
applied; and

[0022]FIG. 6 is a schematic, perspective view of another illustrative
embodiment of a closing bolster.

DETAILED DESCRIPTION

[0023] In the following detailed description of the illustrative
embodiments, reference is made to the accompanying drawings that form a
part hereof, and in which is shown by way of illustration specific
preferred embodiments in which the invention may be practiced. These
embodiments are described in sufficient detail to enable those skilled in
the art to practice the invention, and it is understood that other
embodiments may be utilized and that logical structural, mechanical,
electrical, and chemical changes may be made without departing from the
spirit or scope of the invention. To avoid detail not necessary to enable
those skilled in the art to practice the invention, the description may
omit certain information known to those skilled in the art. The following
detailed description is, therefore, not to be taken in a limiting sense,
and the scope of the present invention is defined only by the appended
claims.

[0024] Referring to FIGS. 1 and 2 an illustrative embodiment of a
reduced-pressure linear wound closing system 100 for treating a linear
wound 102, such as a laceration or, more typically, an incision 104 is
presented. Linear wound 102 has a first edge 106 and a second edge 108.
While linear wound 102 may extend to different depths, it is shown as an
incision 104 extending through epidermis 110, dermis 112, and into
subcutaneous tissue, or hypodermis, 114.

[0025] A dressing assembly 118 may be placed over the linear wound 102 and
used with reduced pressure to supply an inward, or closing, force 120,
and a compressive force 122 may be developed as well. Dressing assembly
118 includes a closing bolster 126 that is moveable between an extended
position (e.g., FIG. 1) and a compression position. A sealing subsystem
178 provides a fluid seal between the dressing assembly 118 and the
patient's epidermis 110. A reduced-pressure subsystem 188 provides
reduced pressure to an interior portion of the dressing assembly 118 and
causes the closing bolster 126 to be urged from the extended position to
the compressed position and thereby provides the inward, closing force
124 to both edges 106, 108 of the linear wound 102.

[0026] Closing force 120 remains primarily within epidermis 110 and dermis
112. The closing force 120 may provide a smooth, tight approximation of
edges 106 and 108 of the linear wound 102. In addition, system 100 is
operable to deliver a reduced pressure to incision 104 that may also be
realized at the level of any subcutaneous voids to help
approximate--bring together--the tissues in that region as well as to
help remove any air or any other fluids. The term "fluid" as used herein
generally refers to gas or liquid, but may also include any other
flowable material. A downward (for the orientation of FIG. 1) compression
force 122 may also be developed.

[0027] The dressing assembly 118 may include closing bolster 126 and
over-drape 180. The closing bolster 126 may be formed in many ways and
has the effect of developing a closing force 120 when placed under
reduced pressure. System 100 may further provide a compressive force 122,
and at the same time, manifold reduced pressure to the linear wound 102
for reduced-pressure treatment.

[0028] In the illustrative embodiment of FIG. 1, closing bolster 126 is
formed with a pivotable frame 130. To form the pivotable frame 130 of
FIG. 1, a first closing member 132, second closing member 146, and a
connection member 160 are coupled as will be described. The members of
pivotable frame 130 may be made of any material, e.g., a medical grade
silicone. The members of the pivotable frame 130 may be extruded, pour
molded, injection molded, blow molded, or formed by other manufacturing
techniques. The pivotable frame 130 is open on the ends (first end and
second end, or proximal end and distal end) as the pivotable frame is
deployed on the epidermis 110 and over the linear wound 102, but is
covered by the over-drape 180 for use.

[0029] The first closing member 132 has a first longitudinal edge 134,
second longitudinal edge 136, a first lateral edge (analogous to lateral
edge 238 in FIG. 3B), second lateral edge (analogous to lateral edge 240
in FIG. 3B), an interior surface 142, and a lateral axis 144 (FIG. 2).
Similarly, the second closing member 146 has a first longitudinal edge
148, second longitudinal edge 150, a first lateral edge (analogous to
lateral edge 252 in FIG. 3B), second lateral edge (analogous to lateral
edge 254 in FIG. 3B), an interior surface 156, and a lateral axis
analogous to axis 144 (FIG. 2). The connection member 160 has a first
longitudinal edge 162, a second longitudinal edge 164, a first lateral
edge (analogous to first lateral edge 266 in FIG. 3B), and a second
lateral edge (analogous to second lateral edge 268 in FIG. 3B).

[0030] The first longitudinal edge 134 of the first closing member 132 is
pivotably coupled by a first pivot connector 170 to the first
longitudinal edge 162 of the connection member 160. The first
longitudinal edge 148 of the second closing member 146 is pivotably
coupled by a second pivot connector 172 to the second longitudinal edge
164 of the connection member 160. Together, the pivotably coupled first
closing member 132, second closing member 146, and connection member 160
form the pivotable frame 130 and further defines an interior space 174.
In one variation, the pivotable frame 130 may be formed by using a first
pivot connector to couple the first longitudinal edge 134 of the first
closing member 132 to the first longitudinal edge 148 of the second
closing member 146.

[0031] The first pivot connector 170 may be any device or system that
holds the first longitudinal edge 134 of the first closing member 132 to
the first longitudinal edge 162 of the connection member 160 (or first
longitudinal edge 143 of the second closing member 146) and allows
relative movement. The first pivot connector 170 may be, for example, a
piano hinge, a living hinge, butterfly hinge, strap hinge, a
filament-tape connection, tape, etc. The pivot connector 170 may also be
a relief in a sheet of material that allows the sheet to fold and bend
along an edge. The other connectors herein, e.g., connector 172, may also
be any type of connector, such as those referenced in this paragraph.

[0032] A first gripping member 145 may be associated with the second
longitudinal edge 136 of the first closing member 132, and a second
gripping member 159 may be associated with the second longitudinal edge
150 of the second closing member 146. The gripping member 145, 159 may be
a first adhesive strip 147 and a second adhesive strip 161, respectively.
Alternatively, the edges 136, 150 may have high-friction members, e.g.,
soft silicone, added that are able to provide a friction interface with
the skin such that as the edges 136, 150 are moved the skin moves with
the edges 136, 150 without any significant slipping therebetween. The
gripping member 145 and 159 are operable to transmit the inward, closing
forces 120 from the closing members 132 and 146 to the patient's skin and
thereby urge the edges 106 and 108 of the linear wound 102 into close
approximation.

[0033] A manifold member 175 is disposed within the interior space 174 of
the pivotable frame 130 and may be coupled to the interior surface 142 of
first closing member 132 and to the interior surface 156 of second
closing member 146. In an alternative embodiment, the manifold member 175
may not be coupled to the interior space 174 and reduced pressure may
primarily move the first closing member 132 and second closing member 146
towards each other. The manifold member 175 contracts when placed under
reduced pressure and is operable to distribute a reduced pressure to the
linear wound 102. The manifold member 175 may be made from many possible
manifold materials.

[0034] The term "manifold" as used herein as a noun generally refers to a
substance or structure that is provided to assist in applying reduced
pressure to, delivering fluids to, or removing fluids from a tissue site.
In one illustrative embodiment, the manifold member 175 is made from a
porous and permeable foam-like material and, more particularly, a
reticulated, open-cell polyurethane or polyether foam that allows good
permeability of wound fluids while under a reduced pressure. One such
foam material that has been used is the VAC® Granufoam® Dressing
available from Kinetic Concepts Inc. (KCI) of San Antonio, Tex. Any
material or combination of materials might be used for the bolster
material provided that the bolster material is operable to manifold the
reduced pressure and contract under reduced pressure. A manifold
typically includes a plurality of flow channels or pathways that are
interconnected to improve distribution of fluids provided to and removed
from the area of tissue around the manifold. Examples of manifolds may
include without limitation devices that have structural elements arranged
to form flow channels, cellular foam such as open-cell foam, porous
tissue collections, and liquids, gels and foams that include or cure to
include flow channels. The bolster material might also be a combination
or layering of materials; for example, a first bolster layer of
hydrophilic foam might be disposed adjacent to a second bolster layer of
hydrophobic foam to form the bolster material.

[0035] The reticulated pores of the Granufoam® material, that are in
the range of about 400 to 600 microns, are helpful in carrying out the
manifold function, but other materials may be used. A material with a
higher density (smaller pore size) than Granufoam® material may be
desirable in some situations. The manifold member 175 may be a
reticulated foam that is later felted to a thickness of about 1/3 the
manifold member's 175 original thickness. Among the many possible
materials, the following might be used: Granufoam® material or a
Foamex technical foam (www.foamex.com). In some instances it may be
desirable to add ionic silver to the foam in a microbonding process or to
add other substances to the manifold member 175 such as antimicrobial
agents. The manifold member 175 may be isotropic or anisotropic depending
on the exact orientation of the forces 120, 122 that are desired during
reduced pressure. The manifold member 175 could also be a bio-absorbable
material.

[0036] Sealing subsystem 178 may include an over-drape 180, or drape,
which has a first side 181 and a second side 182. The over-drape 180
covers the dressing 118 and extends past a peripheral edge 176 of bolster
126 to form a drape extension 183. Drape extension 183 has a first side
184 and a second side 185. A sealing apparatus 186 may be used to seal
the drape extension 183 to the patient. Sealing apparatus 186 may take
numerous forms, such as an adhesive sealing tape 187, or drape tape or
strip; double-side drape tape; adhesive; paste; hydrocolloid; hydrogel;
or other sealing device. If a tape 187 is used, the tape 187 may be
formed of the same material as the over-drape 180 with a pre-applied,
pressure-sensitive adhesive on the second side 185 of the extension 183.
An adhesive might also be used to provide a substantially fluid seal
between the over-drape 180 and the epidermis 110 of the patient. Before
the over-drape 180 is applied to the patient, the adhesive may have
removable strips covering the adhesive removed, or the drape 180 may be
applied and the tape 187 placed to form a seal.

[0037] Over-drape 180 may be an elastomeric material that has pore sizes
less than about 20 microns. "Elastomeric" means having the properties of
an elastomer and generally refers to a polymeric material that has
rubber-like properties. More specifically, most elastomers have
elongation rates greater than 100% and a significant amount of
resilience. The resilience of a material refers to the material's ability
to recover from an elastic deformation. Examples of elastomers may
include, but are not limited to, natural rubbers, polyisoprene, styrene
butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber,
butyl rubber, ethylene propylene rubber, ethylene propylene diene
monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane,
EVA film, co-polyester, and silicones. Over-drape materials may include a
silicone, 3M Tegaderm® drape material, acrylic drape material such as
one available from Avery, or an incise drape material.

[0038] The over-drape 180 may or may not be coupled to the bolster 126. If
coupled, the coupling may occur in many ways. Over-drape 180 and bolster
126 may be coupled using adhesives such as an acrylic adhesive, silicone
adhesive, hydrogel, hydrocolloid, etc. Over-drape 180 and bolster 126 may
be bonded by heat bonding, ultrasonic bonding, and radio frequency
bonding, etc. The coupling may occur in patterns or more completely.
Structure might be added to the bond to make the over-drape 180 behave
anisotropically in a desired direction, i.e. to make an anisotropic drape
material. An anisotropic drape material helps the dressing assembly 118
to primarily move in a given direction, i.e. only about a certain axis or
axes. This may be particularly useful in a closing application.

[0039] Reduced-pressure subsystem 188 includes a reduced-pressure source
189, which can take many different forms. Reduced-pressure source 189
provides a reduced pressure as a part of system 100. The term "reduced
pressure" as used herein generally refers to a pressure less than the
ambient pressure at a tissue site that is being subjected to treatment.
In most cases, this reduced pressure will be less than the atmospheric
pressure at which the patient is located. Alternatively, the reduced
pressure may be less than a hydrostatic pressure of tissue at the tissue
site. It is often desirable for the reduced-pressure source 189 to
develop a continuous reduced pressure below atmospheric pressure and also
to be able to deliver a dynamic pressure, i.e., to vary the reduced
pressure in a cycle or operate in a continuous or intermittent mode. The
operable range of reduced pressure may vary widely as needed, but would
typically include 200 mm Hg below atmospheric. In order to maximize
patient mobility and ease, reduced-pressure source 189 may be a
battery-powered, single-use reduced-pressure generator. Such a pressure
source 189 facilitates application in the operating room and provides
mobility and convenience for the patient during the rehabilitation phase.

[0040] In the illustrative embodiment of FIG. 1, the reduced-pressure
source 189 is shown having a battery compartment 195 and a canister
region 190 with windows 191 providing a visual indication of the level of
fluid within canister 190. An interposed membrane filter, such as
hydrophobic or oleophobic filter, might be interspersed between a
conduit, or tubing, 192 and the reduced-pressure source 189.

[0041] The reduced pressure developed by reduced-pressure source 189 is
delivered through the delivery tube or conduit 192 to an interface 193,
which might be an elbow port 194. In one illustrative embodiment, port
194 is a TRAC® technology port available from KCI of San Antonio,
Tex. Interface 193 allows the reduced pressure to be delivered to the
sealing subsystem 178 and received by the manifold member 175.

[0042] In the embodiment of FIGS. 1 and 2, application of reduced pressure
from the reduced-pressure subsystem 188 causes the manifold member 175 to
contract inward, but because overdrape 180 surrounds the pivotal frame
130, there is also a downward (for the orientation shown) force placed on
the pivotal frame 130. In this particular embodiment, it is desirable to
orient the members of the pivotal frame 130 so that the downward force
will be translated into a contribution to the closing force 120. As shown
in FIG. 2, this may be accomplished by placing the closing members 132
and 146 with an inward orientation. For example, first closing member 132
is shown in cross-section having a lateral axis 144 that makes an angle
α with a reference line or axis 143 that is normal to epidermis
110. Thus, the inward angle α means that as a force is applied
downward on connection member 160, the force will urge first member 132
to pivot about first pivot connection 170 and want to collapse inward.
This helps to urge the epidermis 110 in the direction of the linear wound
102.

[0043] In operation, reduced-pressure, linear wound closing system 100 may
be applied to further assist mechanical closure devices such as sutures
or staples already applied, or may be the only and primary closing source
for linear wound 102. In either case, the system 100 is applied by
placing the first closing member 132 on first wound edge 106 and the
second closing member 146 on the second wound edge 108. Gripping member
145 on second longitudinal edge 136 is used to engage first edge 106 of
the wound 102. In the particular embodiment shown, the first gripping
member 145 is an adhesive strip 147. Thus, the healthcare provider would
remove visible backing from the adhesive strip 147 and the adhesive strip
147 would be applied proximate first edge 106. In a similar manner, the
second gripping member 159 in this embodiment is an adhesive strip 161,
and a backing may be removed and the strip 161 applied proximate the
second edge 108 of the linear wound 102. Adhesive strips 147 and 161 are
applied near edges 106 and 108 in a manner that places the closing
members 132 and 146 at an inward angle as described earlier in connection
with FIG. 2. It should be noted that in this particular embodiment, the
manifold member 175 has already been placed within interior space 174
formed by the pivotal frame 130, but in other applications the manifold
member 175 could be inserted just prior to applying the gripping members
145 and 159 to the epidermis 110. If the overdrape 180 has not already
been coupled to an exterior surface of the pivotable frame 130, the
overdrape 180 is then placed over the frame 130 and caused to extend
beyond the peripheral edges 170 to form the drape extensions 183. In this
particular embodiment, adhesive tape 187 is then applied to make sure a
fluid seal is formed between drape 180 and the patient's epidermis 110.
Reduced-pressure interface 193 is applied and is coupled to delivery tube
192, which in turn is coupled to the reduced-pressure source 189.

[0044] Reduced-pressure source 189 may then be activated to deliver
reduced pressure to the sealing subsystem 178 and in particular to the
manifold member 175. Subject to reduced pressure, manifold member 175
contracts and is compressed down along with the pivotal frame 130. The
combination of forces urges the second lateral edges 140 and 154 towards
each other and towards wound 102, provides some compression force down,
and manifolds reduced pressure to the wound 102.

[0045] Referring to FIGS. 3A, 3B, and 3C, another embodiment of a
reduced-pressure, linear-wound closure system 200 is presented. Many of
the parts are analogous to those of system 100 of FIGS. 1 and 2 and the
possible relationship presented as such by simply indexing the numbers by
100. Referring particularly to FIG. 3A, two particular differences are
noted. First, the sealing subsystem 278 does not involve the use of an
overdrape, but provides a pivotable frame 230 to which a first end cap
263 (FIG. 3B) and a second end cap 265 (FIG. 3B) have been added to form
a fluid seal. The interface 293 allows reduced pressure to be supplied to
the manifold member 275 without compromising the fluid seal. Second, in
application, the closing members 232 and 246 may be allowed to have an
outward angle relative to reference line normal to the epidermis
(analogous to reference line 143 of FIG. 2). This is because in this
embodiment there will not generally be a downward compression force
placed on the pivotable frame 230. The closing members 232 and 246 are
urged together to provide the inward force 220 primarily by contraction
of the manifold member 275. The application of reduced pressure to the
manifold member 275 causes the closing bolster 226 to move from an
extended position shown in FIGS. 3A and 3B to a compression position
shown in FIG. 3C.

[0046] Referring to FIG. 3B, system 200 includes pivotal frame 130, which
is shown positioned with a lengthwise dimension running parallel to wound
axis 203 of linear wound 202. Linear wound 202 has first edge 206 and
second edge 208. The first closing member 232 has first lateral edge 238
and a first longitudinal edge 234. The second closing member 246 has a
first lateral edge 252 and a second lateral edge 254. The second closing
member 246 also has first longitudinal edge 248 and second longitudinal
edge 250.

[0047] End caps 263 and 265 may be formed in a number of different ways to
provide a fluid seal to the ends of the pivotal frame 130. In this
particular embodiment, they are shown as adhesive portions of an
overdrape material that have been applied to cover the end pieces.

[0048] In systems 100 and 200, the reduced pressure delivered by reduced
pressure subsystems 188 and 288 may be supplied in a continuous mode or a
dynamic reduced pressure mode. In a dynamic mode, the pressure is varied
in any number of different types of patterns. For example, referring to
FIG. 4, one particular pattern for the application of reduced pressure is
presented. The ordinate axis 310 gives the reduced pressure. It should be
understood that an increase in reduced pressure here means that a lower
gauge pressure would be shown. The abscissa axis 312 gives the elapsed
time. Thus, in this particular pattern, the reduced pressure is ramped up
to a baseline level 314 and then varied, in this instance, in a
sinusoidal pattern between a greater reduced pressure level 316 and a
lower reduced pressure 318. This variation in reduced pressure causes
micromotion of the wound by varying the closing forces, e.g., the
variation of the closing forces 120 and 220 of the embodiments of FIG. 1
and FIG. 3.

[0049] Referring now to FIG. 5, one of the beneficial effects encouraged
by use of the dynamic pressure, such as the illustration given in
connection with FIG. 4, is presented. A linear wound 402 through
epidermis 410, dermis 412, and even into subcutaneous tissue 414 is
shown. Linear wound 402 has been subjected to dynamic micromotion for
forces 420 which may have been generated by a system such as system 100
or system 200, FIG. 1 and FIG. 3, respectively. The micromotion causes
the collagen 416 to be deposited in the wound 402 with an orientation
that is parallel to the forces 420.

[0050] Referring now to FIG. 6, another embodiment of a system for
providing a closing force to a linear wound is presented. In this system,
an anisotropic bolster 526 is formed with an anisotropic body 528. The
anisotropic body 528 comprises an anisotropic manifold member operable
under reduced pressure to contract more in a lateral direction, i.e,
parallel to force 520, than in a longitudinal, or lengthwise, direction,
i.e., perpendicular to force 520.

[0051] The anisotropic body may be formed in many ways. As one
illustrative embodiment, the bolster body 528 may be formed by utilizing
a plurality of flexible, or compressible, manifold members 530 and a
plurality of reinforcing longitudinal members 532. The plurality of
flexible manifold members 530 may be analogous to the material from which
manifold members 175 and 275 were made in previously described
embodiments. The reinforcing longitudinal members 532 are formed of a
material, or reinforcing material, that inhibits compression along one or
more axes or directions. The reinforcing material may also inhibit
expansion along one or more axes. The reinforcing material may inhibit
both compression and expansion along one or more axes or directions. In
one illustrative embodiment, the reinforcing longitudinal members 532 are
filaments combined with the manifold members 530 to form the bolster body
528. It will be appreciated that for the orientation shown, the resulting
anisotropic bolster body 528 will be able to contract or compress in a
first direction 534, but not in a substantial way in a second direction
536.

[0052] In operation, the anisotropic closing bolster 526 will be placed
down on a linear wound with the lengthwise dimension of the plurality of
reinforcing members 532 running parallel to the wound, i.e., with the
linear wound substantially parallel to direction 536. An overdrape
analogous to drape 180 of system 100 may be applied over the bolster 526
and an interface, which is analogous to interface 193 of FIG. 1, may be
applied in order to deliver reduced pressure. When reduced pressure is
delivered to the anisotropic closing bolster 526, it will contract in the
first direction 534 and this causes inward forces 520 to be directed on
both edges of the wound, providing a closing force. The reduced pressure
supplied to anisotropic bolster 526 may be dynamically varied as
previously discussed or provided in a constant mode.

[0053] It should be apparent from the foregoing that an invention having
significant advantages has been provided. While the invention is shown in
only a few of its forms, it is not just limited but is susceptible to
various changes and modifications without departing from the spirit
thereof.

Patent applications by Charles Alan Seegert, San Antonio, TX US

Patent applications in class Means to draw opposed sides of incision into apposition

Patent applications in all subclasses Means to draw opposed sides of incision into apposition